Oncaspar

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For Patients

Oncaspar (pegaspargase) is used to treat acute lymphoblastic leukemia. It is a cancer (antineoplastic) medication. Common side effects include nausea, vomiting, weakness, loss of appetite, diarrhea, dizziness, or pain/swelling/redness at injection site.

The recommended dose of Oncaspar is 2,500 IU/m² intramuscularly (IM) or intravenously (IV). It should be administered no more frequently than every 14 days. Oncaspar may interact with vincristine, prednisone, or methotrexate. Tell your doctor all medications and supplements you use. During pregnancy, Oncaspar should be used only when prescribed. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Oncaspar (pegaspargase) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

SIDE EFFECTS: Nausea, vomiting, weakness, loss of appetite, diarrhea, or pain/swelling/redness at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, signs of an infection (e.g., fever), increased thirst/urination, easy bruising/bleeding, dark urine, yellowing eyes/skin, pain/redness/swelling/numbness/tingling of the arms or legs, change in the amount of urine.

Get medical help right away if any of these rare but very serious side effects occur: sudden shortness of breath, chest pain, severe headache, seizures, slurred speech, confusion, vision changes, weakness on one side of the body.

A very serious allergic reaction to this drug can occur. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, the adverse reaction rates observed cannot be directly
compared to rates in other clinical trials and may not reflect the rates
observed in clinical practice.

First-Line ALL

The data presented below are derived from 2 studies in
patients with standard-risk ALL who received Oncaspar® as a
component of first-line multi-agent chemotherapy. Study 1 was a randomized
(1:1), active-controlled study that enrolled 118 patients, with a median age of
4.7 years (1.1-9.9 years), of whom 54% were males and 65% White, 14% Hispanic,
8% Black, 8% Asian, and 6% other. Of the 59 patients in Study 1 who were
randomized to Oncaspar® , 48 patients (81%) received all 3 planned
doses of Oncaspar®, 6 (10%) received 2 doses, 4 (7%) received 1
dose, and 1 patient (2%) did not receive the assigned treatment. Study 2 is an
ongoing, multi-factorial design study in which all patients received Oncaspar® as a component of various multi-agent chemotherapy regimens; interim
safety data are available for 2,770 patients. Study participants had a median
age of 4 years (1-10 years), and were 55% male, 68% White, 18% Hispanic, 4%
Black, 3% Asian, and 7% other. Per protocol, the schedule of Oncaspar® varied
by treatment arm, with intermittent doses of Oncaspar® for up to 10
months.

In Study 1, detailed safety information was collected for
pre-specified adverse reactions identified as asparaginase-induced adverse
reactions and for grade 3 and 4 non-hematologic adverse reactions according to
the Children's Cancer Group (CCG) Toxicity and Complication Criteria. The
per-patient incidence, by treatment arm, for these selected adverse reactions
occurring at a severity of grade 3 or 4 are presented in Table 1 below:

Safety data were collected in Study 2 only for National
Cancer Institute Common Toxicity Criteria (NCI CTC) version 2.0, grade 3 and 4
non-hematologic toxicities. In this study, the per-patient incidence for the
following adverse reactions occurring during treatment courses in which
patients received Oncaspar® were: elevated transaminases, 11%;
coagulopathy, 7%; hyperglycemia, 5%; CNS thrombosis/hemorrhage, 2%;
pancreatitis, 2%; clinical allergic reaction, 1%; and hyperbilirubinemia, 1%.
There were 3 deaths due to pancreatitis.

Previously Treated ALL

Adverse reaction information was obtained from 5 clinical
trials that enrolled a total of 174 patients with relapsed ALL who received
Oncaspar® as a single agent or in combination with multi-agent
chemotherapy. The toxicity profile of Oncaspar® in patients with
previously treated relapsed ALL is similar to that reported above with the
exception of clinical allergic reactions (see Table 2). The most common adverse
reactions of Oncaspar® were clinical allergic reactions, elevated
transaminases, hyperbilirubinemia, and coagulopathies. The most common serious
adverse events due to Oncaspar® treatment were thrombosis (4%),
hyperglycemia requiring insulin therapy (3%), and pancreatitis (1%).

Allergic Reactions

First-Line ALL

Among 58 Oncaspar®-treated patients enrolled
in Study 1, clinical allergic reactions were reported in 2 patients (3%). One
patient experienced a grade 1 allergic reaction and the other grade 3 hives;
both occurred during the first delayed intensification phase of the study (see
Table 2).

Previously Treated ALL

Among 62 patients with relapsed ALL and prior
hypersensitivity reactions to asparaginase, 35 patients (56%) had a history of
clinical allergic reactions to native Escherichia (E.) coli L-asparaginase,
and 27 patients (44%) had a history of clinical allergic reactions to both
native E. coli and native Erwinia L-asparaginase. Twenty (32%) of
these 62 patients experienced clinical allergic reactions to Oncaspar® (see
Table 2).

Immunogenicity

As with all therapeutic proteins, there is a potential
for immunogenicity, defined as development of binding and/or neutralizing
antibodies to the product.

In Study 1, Oncaspar®-treated patients were
assessed for evidence of binding antibodies using an enzyme-linked
immunosorbent assay (ELISA) method. The incidence of protocol-specified
“high-titer” antibody formation was 2% in Induction (n=48), 10% in Delayed
Intensification 1 (n=50), and 11% in Delayed Intensification 2 (n=44). There is
insufficient information to determine whether the development of antibodies is
associated with an increased risk of clinical allergic reactions, altered
pharmacokinetics, or loss of anti-leukemic efficacy.

The detection of antibody formation is highly dependent
on the sensitivity and specificity of the assay, and the observed incidence of
antibody positivity in an assay may be influenced by several factors including
sample handling, concomitant medications, and underlying disease. Therefore,
comparison of the incidence of antibodies to Oncaspar® with the
incidence of antibodies to other products may be misleading.